Branched frozen elephant trunk device and method

Abstract

An endoluminal prosthesis system includes a graft having a tubular body with a proximal end and a distal end. A lumen extends from the proximal end to the distal end. A proximal portion of the graft includes the proximal end; a distal portion of the graft includes the distal end; and a middle portion of the graft extends from the proximal portion to the distal portion. A plurality of connection branches are attached to the middle portion. Each of the connection branches has an inner opening at an inner end attached to the middle portion and an outer opening at an outer end disposed radially outwardly from the inner end. Each of the connection branches is pivotable in a proximal and distal direction and a circumferential direction relative to the middle portion. Further, each of the connection branches includes an expandable seal stent at the outer end.

What is claimed is: 
     
       1. An endoluminal prosthesis system for being deployed in a patient's aorta near the heart, the system comprising:
 a graft having a tubular body with a proximal end and a distal end, where the proximal end is an end configured to be deployed near a patient's heart and the distal end is an end configured to be deployed away from the patient's heart, the tubular body defining a lumen extending from the proximal end to the distal end; 
 an unstented proximal portion of the graft including the proximal end; 
 a stented distal portion of the graft including the distal end; 
 a stented middle portion of the graft extending from the proximal portion to the distal portion; 
 a collar disposed at a junction defining an intersection between the stented distal portion and the stented middle portion whereby stents are provided proximally and distally of the collar; 
 a plurality of connection branches attached to the stented middle portion, each of the connection branches having a first end attached to the stented middle portion at an interface of flexible graft material between the first end and the stented middle portion and a second end disposed radially outwardly from the first end, the first end defining a first opening and the second end defining a second opening, and a lumen extending from the first opening to the second opening; 
 wherein each of the connection branches is pivotable in a proximal and distal direction and a circumferential direction relative to the stented middle portion at the interface between the first end of the connection branch and the stented middle portion; 
 wherein each of the connection branches includes a seal stent disposed at the outer end, the seal stent being radially expandable to engage a branch vessel wall. 
 
     
     
       2. The system of  claim 1 , wherein the stented middle portion of the graft comprises a plurality of unstented regions and each interface is disposed within an unstented region of the plurality of unstented regions. 
     
     
       3. The system of  claim 2 , wherein the unstented proximal portion includes a side branch extending radially outward from the proximal portion and providing fluid communication into the lumen of the graft. 
     
     
       4. The system of  claim 1 , wherein each of the first ends of the connection branches is sewn to the interface of the flexible portion of graft material. 
     
     
       5. The system of  claim 4 , wherein each of the connection branches are pivotable relative to the graft at attachment portions via the interface of the flexible graft material. 
     
     
       6. The system of  claim 1 , wherein the connection branches have a compressed delivery configuration and an expanded deployed configuration. 
     
     
       7. The system of  claim 6 , wherein the first end of each of the connection branches does not extend into the lumen of the graft, either in the delivery configuration or in the deployed configuration. 
     
     
       8. The system of  claim 6 , wherein the connection branches are compressed within a peel-away sheath in the delivery configuration, wherein the peel-away sheath is disposed outside of the lumen of the graft. 
     
     
       9. The system of  claim 6 , further comprising a plurality of wires configured to extend through the connection branches and out of the distal end of the graft in the delivery configuration. 
     
     
       10. The system of  claim 1 , wherein at least one of the connection branches is stented via at least one additional stent disposed between the seal stent and the first end. 
     
     
       11. An endoluminal prosthesis system for being deployed in a patient's aorta near the heart, the system comprising:
 a graft having a tubular body of graft material with a proximal end and a distal end and a sidewall, where the proximal end is an end configured to be deployed near a patient's heart and the distal end is an end configured to be deployed away from the patient's heart, the tubular body defining a lumen extending from the proximal end to the distal end; 
 an unstented proximal portion of the graft including the proximal end; 
 a stented distal portion of the graft including the distal end; 
 a stented middle portion of the graft extending from the proximal portion to the distal portion; 
 a plurality of connection branches extending from the stented middle portion, each of the plurality of connection branches having an open end attached to the sidewall of the tubular graft at an interface of flexible graft material between the open end and the sidewall, the flexible interface comprising additional graft material; 
 a collar disposed at a junction defining an intersection between the stented distal portion and the stented middle portion and distal of the plurality of connection branches such that stents are provided proximally and distally of the collar; 
 wherein the connection branches are pivotable relative to the tubular graft via the interface of flexible graft material; and 
 wherein the connection branches have a compressed delivery configuration and a radially expanded deployed configuration, wherein each of the connection branches is deliverable along a respective wire in the delivery configuration and expandable into engagement with a branch vessel wall in the deployed configuration. 
 
     
     
       12. The system of  claim 11 , wherein each of the connection branches has a second open end with an internal seal stent. 
     
     
       13. The system of  claim 11  further comprising a plurality of the wires, over which the connection branches are deliverable in the delivery configuration. 
     
     
       14. The system of  claim 11 , wherein the distal portion has a compressed delivery configuration and an expanded deployed configuration and is expandable from the delivery configuration to the deployed configuration separately from the proximal portion and the middle portion. 
     
     
       15. The system of  claim 11 , wherein the middle portion has a compressed delivery configuration and an expanded deployed configuration and is expandable from the delivery configuration to the deployed configuration separately from the proximal portion and the distal portion. 
     
     
       16. The system of  claim 11 , wherein an innermost end of each of the connection branches does not extend into the lumen of the graft. 
     
     
       17. The system of  claim 11 , wherein each of the connection branches is sewn to a graft material of the graft at an attachment interface between the connection branch and the graft, and the branches are pivotable relative to the graft at the attachment interface. 
     
     
       18. An endoluminal prosthesis comprising:
 a tube of graft material having an inflow end, an outflow end, a lumen, and a sidewall between the inflow end and the outflow end, the tube of graft material comprising,
 an entirely unstented proximal region, 
 a stented distal region comprising a plurality of discrete stents, 
 a stented middle region between the entirely unstented proximal region and the stented distal region and comprising a plurality of discrete stents, wherein the entirely unstented proximal region is made from a graft material different than the graft material of the stented middle region, 
 a plurality of branches, each having a first open end and a second open end, disposed in and extending from the stented middle region, wherein each open end of the plurality of branches is attached to an interface region of flexible graft material disposed between each open end of the plurality of branches and the sidewall such that each of the plurality of branches is pivotable relative to the sidewall, and 
 a collar disposed at a junction between the stented middle region and the stented distal region and distal of the plurality of branches such that stents are provided proximally and distally of the collar. 
 
 
     
     
       19. The endoluminal prosthesis of  claim 18 , wherein the graft material of the entirely unstented proximal region comprises crimps along a length of the proximal region and the graft material of the stented middle region does not comprise crimps. 
     
     
       20. The endoluminal prosthesis of  claim 18 , wherein at least a portion of each of the plurality of branches is disposed within the lumen.